Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
Overview
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
Full Title of Study: “Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: May 2011
Interventions
- Drug: Alprazolam tablet
- 1 mg single dose of alprazolam conventional tablet
- Drug: Alprazolam sublingual
- 1 mg single dose of alprazolam sublingual tablet
Arms, Groups and Cohorts
- Active Comparator: Alprazolam conventional tablet
- Alprazolam conventional tablet
- Experimental: Alprazolam sublingual tablet
- Alprazolam sublingual tablet
Clinical Trial Outcome Measures
Primary Measures
- Area under the curve (AUC) from time zero to last measurable time of alprazolam
- Time Frame: 72 hours
- Peak concentration of alprazolam
- Time Frame: 72 hours
Secondary Measures
- Area under the curve from time zero to infinity
- Time Frame: 72 hours
- AUC% extrapolated
- Time Frame: 72 hours
- Time of Cmax
- Time Frame: 72 hours
- half-life of alprazolam
- Time Frame: 72 hours
- Clinically significant safety laboratory tests
- Time Frame: Screening, Day 0, Day 4
- Clincally significant vital signs
- Time Frame: Screening, Day 4
- Clinically significant adverse events
- Time Frame: 1 month
Participating in This Clinical Trial
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. – Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. – Signed informed consent. Exclusion Criteria:
- Evidence or history of clinically significant abnormalities – Positive drug screen, excessive alcohol and tobacco use
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
- Provider of Information About this Clinical Study
- Director, Clinical Trial Disclosure Group, Pfizer, Inc.
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
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